Remote IT Quality Assurance & Compliance Lead

ICU Medical Inc; Springfield (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

ICU Medical is seeking a Manager, IT Assurance and Compliance - Quality Systems to lead the IT Quality Compliance program across global operations. You will drive audits, regulatory alignment, and continuous improvement in CSA, SQM, and QMS processes.

The role emphasizes automation, analytics, and cross-functional collaboration to mitigate risks and enhance quality and efficiency. This position is remote, with travel less than 10% as needed.

Qualifications

• Bachelor's degree in sciences, engineering, IT, or related field.
• 10+ years in IT quality assurance, compliance, and regulated environments.
• Experience with FDA inspections and global quality systems.

Responsibilities

• Lead IT Quality Systems Assurance and Compliance program, including audits.
• Coordinate audits, inspections, and corrective action development.
• Oversee validation and control of computer systems per regulatory requirements.

Skills

Regulatory compliance

Audit management

21 CFR Part 11

GxP & SOX

Automation & analytics

Training & communication

Cross-functional leadership

Education

Bachelor's degree in sciences/engineering/IT

Tools

eQMS

Smartsheet

MS Office (Word/Excel/PowerPoint)

Test management tools

Job description

ICU Medical is seeking a Manager, IT Assurance and Compliance - Quality Systems to lead the IT Quality Compliance program across global operations. You will drive audits, regulatory alignment, and continuous improvement in CSA, SQM, and QMS processes.

The role emphasizes automation, analytics, and cross-functional collaboration to mitigate risks and enhance quality and efficiency. This position is remote, with travel less than 10% as needed.